A Phase 1a, Open-label, Multicenter, Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB548 in Participants With Advanced Solid Malignancies With a KRAS G12D Mutation
Kumquat Biosciences Inc.
Summary
The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548. The main questions it aims to answer are: * What is the safe dose of KQB548? * Does KQB548 decrease the size of the tumor? * What happens to KQB548 in the body?
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Pathologically confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation * Progressed on, or intolerant to at least one prior line of systemic standard of care therapy * Measurable disease according to RECIST v1.1 * Adequate organ function Exclusion Criteria: * Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor * History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled naus…
Interventions
- DrugKQB548
Oral KQB548
Locations (12)
- University of California, San DiegoLa Jolla, California
- University of California, Los AngelesLos Angeles, California
- SCRI - DenverDenver, Colorado
- University of Miami - Sylvester Comprehensive Cancer CenterMiami, Florida
- START MidwestGrand Rapids, Michigan
- The Christ HospitalCincinnati, Ohio